Merck announces publication of GARDASIL pivotal Phase III study data in NEJM

Merck announced today that data from the pivotal Phase III study with GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] in males were published in the February 3 issue of the New England Journal of Medicine (NEJM). In this study, GARDASIL was 89 percent effective against human papillomavirus (HPV) types 6- and 11- related genital warts in males aged 16 through 26. This Phase III study is the only study to demonstrate the efficacy of an HPV vaccine in males, and provided data that supported the U.S. Food and Drug Administration (FDA) approval of GARDASIL in October 2009 for the prevention of genital warts caused by HPV types 6 and 11 in boys and men ages 9 to 26 years.

In December 2010, GARDASIL was approved for the prevention of anal cancer caused by HPV types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age, based on a substudy within this Phase III study.

"This publication as well as the recent FDA approval of GARDASIL to prevent anal cancer caused by HPV types 16 and 18 underscores the importance of vaccinating both males and females to help prevent certain HPV-related diseases," said Dr. Anna Giuliano, chair, Department of Epidemiology and Genetics, and Program Leader Cancer Epidemiology at the Moffitt Cancer in Tampa, Florida, and the study's lead author.

GARDASIL helps protect against the four types of HPV, specifically types 6, 11, 16, and 18, that cause the most disease. It is estimated that HPV types 16 and 18 account for approximately 80 percent of anal cancers, 75 percent of cervical cancers, 70 percent of vaginal cancers and 40 to 50 percent of vulvar cancers. HPV types 6 and 11 cause approximately 90 percent of all genital warts cases.




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